A QA Associate is required for a biopharmaceutical company in Cork.
- Provide QA support to the site for drug substance GMP operations (Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, Automation and Process Engineering, MES, QA Validation and Capital Projects).
- Participate within inter-departmental and cross-functional teams to immediately address issues in real time.
- Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
- Review of MES Exceptions.
- Support lot release activities/schedule including preparation of BDS/FBDS lot files.
- Daily presence and support in the process teams and on the manufacturing floor including walk-through of process issues and RCAR support.
- Release of Raw Materials for drug substance production.
- Review and approve deviations and QC LIR reports to ensure that root causes have been identified, appropriate corrective actions have been implemented and appropriate impact assessments are complete.
- Review and approve Change Control documents pertaining to Warehouse/material operations,
- Upstream/Downstream and Support Services manufacturing, QC In process/Micro, Automation and Process Engineering, QA Validation, IT/CSV and Capital Projects to ensure changes are appropriately assessed and all required actions are identified and implemented.
- Review and approval of process and equipment validation/qualification protocols/reports.
- Review and approval of master batch records on MES.
- Write, review and approve SOPs, Work Instructions, Quality Technical Agreements, Specifications, Quality Risk Assessments, PDD, PCRA and other GMP documentation in accordance with our client’s Policies.
- Conduct Periodic Review of QA SOPs.
- Review and approval of Supplier Change Notifications.
- Assist with preparation of Annual Product Review documents (APRs) and YBPRs (Yearly Biological Product Reports).
- Support cross-training of team members.
- Support quality systems on site.
- Support site inspection readiness activities and provide assist with audits and regulatory inspections, as required.
- Support and drive Continuous Improvement/Lean initiatives on site.
- Compile and present metrics as required.
- Other duties as assigned.
Qualifications & Experience:
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
- Minimum 3-5 years relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Regulatory Compliance.
- Demonstrated experience in supporting manufacturing operations, batch record review, MES and deviation/CAPA is highly desirable.
- Experience with batch release activities is an advantage.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
- Ability to coach junior QA staff.
- Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
To apply for this job email your details to firstname.lastname@example.org.